TW200817471A - Wettable silicone hydrogel contact lenses and related compositions and methods - Google Patents

Abstract

Silicone hydrogel contact lenses having ophthalmically acceptable surface wettabilities are obtained from pre-extracted polymerized silicone hydrogel contact lens products produced from a polymerizable composition comprising a combination of particular components. The silicone hydrogel contact lenses can be obtained from non-polar resin based contact lens molds and without surface treatments or an interpenetrating polymeric network of a polymeric wetting agent. Related lens products, polymerizable compositions, and methods are also described.

Description

200817471 IX. DESCRIPTION OF THE INVENTION: TECHNICAL FIELD OF THE INVENTION The present invention is particularly directed to helium oxygenated hydrogel ophthalmic devices and related compositions and methods. More particularly, the present invention relates to molded wettable hydrogel hydrogel contact lenses and related compositions and methods. [Prior Art] • Hydrogenated hydrogel contact lenses have become popular because contact lens wearers wear these glasses on their eyes for longer than non-oxygenated hydrogel contact lenses. The ability of time. For example, depending on the particular lens, the oxygenated hydrogel contact lens can be worn daily, worn weekly, bi-weekly or worn on a monthly basis or worn or worn every day. , wear in two weeks or wear on the mother's moon. The wearer of the lens wearer associated with the Shixi oxygen hydrogel contact lens can be at least partially attributed to the combination of the hydrophilic component of the contact lens and the hydrophobic character of the stone-containing polymeric material. Non-stone-oxygen hydrogel contact lenses (such as hydrogel contact lenses based on 2-hydroxyethyl methacrylate 0 (HEM A)) are often found in non-polar resin contact lens molds (eg, invisible from polyolefin-based resins) Produced in the glasses mold). A lens precursor composition for a non-oxygenated hydrogel contact lens is polymerized in a non-polar resin contact lens mold to produce a HEMA-based polymeric lens product. Due to the hydrophilic nature of the polymeric components of HEMA-based contact lenses, HEMA-based lenses are still eye-compatible and have an ophthalmically acceptable surface wettability, even if they are produced using a non-polar resin mold. In contrast, prior art oxygenated hydrogel contact lenses obtained from non-polar resin molds have hydrophobic eyeglass surfaces. In other words, the surface of the hydrogen peroxide hydrogel 121842.doc 200817471 has a low wettability and is therefore incompatible or unacceptable to the eye. For example, such a oxy-hydrogel contact lenses can be associated with less desirable features such as increased lipid deposition, protein deposition, spectacles, and the following: > /, the combination of the eye surface and the general stimulation of the glasses wearer. In an effort to overcome these problems, attempts have been made to use (4) Shixi oxygen hydrogel contact lenses or spectacles products for surface treatment + main enamel treatment or surface modification to increase the hydrophilicity and wettability of the enamel surface. Examples of surface treatment of Shixi oxygen hydrogel glasses include coating the surface of the lens, adsorbing chemicals onto the surface of the lens, and changing the chemical nature or electrostatic charge of the chemical groups on the surface of the lens. Surface treatments have been described which include coating the surface of the polymeric lens with a plasma gas or using a plasma gas on the surface of the contact lens mold to treat the cookware prior to forming the polymeric lens. Unfortunately, several disadvantages are associated with this approach. The surface treatment of the hidden mirror requires more mechanical and time to produce the contact lens than a manufacturing method that does not use surface treatment or modification. In addition, the surface treated Weishui (4) contact lens can exhibit no reduced surface wettability when the glasses are worn and/or touched by the glasses. For example, increasing the touch on surface treated glasses can result in degradation or wear of the hydrophilic surface. Another method for increasing the wettability and eye compatibility of (IV) oxygen hydrogel glasses is to polymerize the invisible hydrogel in the presence of a second composition comprising a polymeric wetting agent such as polyvinylpyrrole (tetra) (PVP). A lens precursor composition. This type of lens is herein referred to as a hydrogenated hydrogel contact lens having a polymeric internal wetting agent, and typically comprises a high molecular weight polymer (such as pvp). Wearing a polymer network (IpN). As is familiar to the skilled person, 121842.doc 200817471 understands that IPN refers to a combination of two or more different polymers in a network form, at least one of which is in another Synthesizing and/or cross-linking in the presence of a polymer without any covalent bond between the two. IpN can be composed of two chains that form two separate but adjacent or interpenetrating networks. Examples of IpN include stepwise Π> Ν, Synchronous IPN, Semi-IPN, and both. Although helium-hydrogel contact lenses including polymeric wet IPN avoid problems associated with surface treatment, such glasses may not retain their eye compatibility for extended periods of time, including table Humidity. For example, since the internal humectant is not covalently bonded to form other components of the polymeric spectacles, it may be leached from the spectacles when worn by the spectacles wearer, and thereby the surface may be rendered over time Reduced wetness and increased discomfort of the wearer of the lens. As an alternative to the surface treatment or the use of polymeric wetting agent IPN as described above, it has been found that a polar resin mold can be used instead of a non-polar resin mold to produce an ophthalmically acceptable Surface wettable hydrogel contact lenses. For example, hydroxyl hydrogel contact lenses formed in ethylene-vinyl alcohol based or polyvinyl alcohol based molds have the desired surface wettability. An example of a polar resin for producing a contact lens mold for producing a non-polymerized wetting agent IPN without surface treatment, is an ethylene-ethylene alcohol copolymer resin such as Nippon Gohsei, Ltd. The ethylene-vinyl alcohol copolymer resin sold under the trade name SOARLITETM. In addition to its polarity, SOARLITEtm is described as having the following characteristics: extremely high mechanical strength, resistance Electrostatic, low shrinkage when used in the molding process, excellent oil and solvent resistance, small coefficient of thermal expansion and good wear resistance. Although SOARLITETM based molds are used without surface treatment or 121842.doc 200817471 The polymeric wetting agent IP N produces an eye-compatible oxygenated hydrogel contact lens that provides an advantageous alternative, but the S0ARLITETM mold is more deformable or flexible than a non-polar resin mold such as a polypropylene mold. Small and relatively difficult to work with non-polar resin molds.

From the above, it can be seen that there is a need for an ophthalmically compatible hydroxyl hydrogel contact lens that is easier to produce than a hydrogel contact lens obtained from a soaruteTM contact lens mold, and that does not require surface treatment or polymerization. Agent IPN (including PVP IPN) to achieve eye compatibility. In addition, it is highly desirable to provide an ophthalmicly compatible hydroxyl hydrogel contact lens from a non-polar or polyolefin-based contact lens mold member, such as a lens product having features on the eye that contribute to long-term comfort. The present invention satisfies the need for such surface wettable hydrogel contact lenses, which overcomes the shortcomings of prior art manufacturing methods. That is, there is a need for an improved method for preparing a compatible oxygenated water-eye lens on the eye which does not require surface treatment of the resulting contact lens product, and does not require the use of polymeric wet-test as a polymerizable hydrogel. Portions of Contact Lens Precursor Compositions Provided </ RTI> The present invention provides contact lenses, spectacles products, compositions and methods that address the needs and problems associated with prior oxyhydrogel contact lenses and their current methods of production. It has been found that eye-sharing money (four) shaped glasses are by combining certain components to provide a polymerizable combination of pre-extracted poly-hydrogenated hydrogel contact lens products having one or more particularly desirable characteristics upon polymerization. Things to get. In one or more implementations, prior to the withdrawal, the 121842.doc 200817471 hydrogel contact lens product has an extractable component of about 9% by weight or more. In certain embodiments, the pre-extracted neohydrogen hydrogel contact lens product has an extractable content of at least about 20% by weight. For example, the pre-extracted hemioxy-hydrogel contact lens product can have an extractables content of from about 22% to about 3% by weight. In at least one specific embodiment, the pre-extracted oxalate hydrogel contact lens product has an extractables content of about 26% by weight. In one or more embodiments of the products and methods of the present invention, provided herein is a rock oxide oxygen gel contact lens product that does not utilize a polyoxyn oxide oxygen extractable component, but which advantageously results in an existing lens Compositions and glasses having different and desirable characteristics. Features of the oxygenated hydrogel contact lenses provided herein include ophthalmically acceptable surface wettability as described herein. In addition, the oxygenated hydrogel contact lenses of the present invention have oxygen permeability, surface wettability, modulus, water content, ion flow, and design, which make the glasses of the present invention suitable for comfortable stretching of the patient's eyes. Such as at least one day, at least one week, at least two weeks, or about one month without removing the glasses from the eyes. In one aspect, the invention is directed to a polymerizable silicone hydrogel contact lens precursor composition. The precursor compositions effectively form a helium oxygen hydrogel contact lens. In a particular aspect, provided herein is a polymerizable composition comprising, consisting essentially of, or consisting entirely of: bis(methacryloxyethylethylamino carboxy ethoxy propyl) ()) poly(didecyloxyne)_poly(trifluoropropylmethyl decane poly(ω-methoxy-poly(ethylene glycol) propylmethyl decane), Ν_ethylene Ν-Ν_methylacetamide, methacrylic acid A 121842.doc 200817471 ester, ethylene glycol dimethacrylate, allyloxy alcohol and a free radical initiator. In one or more embodiments, The polymeric composition further comprises a UV absorber such as 2-hydroxy-4-pyreneoxyethoxybenzophenone. In one or more other embodiments, the polymerizable composition further comprises a colorant, such as phthalocyanine a pigment, such as phthalocyanine blue. In one or more other embodiments, the free radical initiator included in the polymerizable composition is 2,2'-azobisisobutyronitrile. The invention further includes the above Any one or more of the polymerizable compositions comprising about 34% by weight of alpha _ _ bis (methyl propylene) Oxyethylimide sulfoethoxypropyl)-poly(dimethyloxoxime)_poly(trimethylpropylmethyloxane)-poly(ω_methoxy-poly(B) Glycol) propyl fluorenyl oxane. In one or more other embodiments, the polymerizable composition can comprise any one or more of the following: (1) about 46% by weight of hydrazine vinyl Ν Ν methyl Acetamide, (ii) about 17% by weight of methyl methacrylate, (丨11) about 5% by weight of ethylene glycol dimethacrylate, and (% by weight of allyloxyl alcohol) In one or more other embodiments, the polymerizable composition comprises about q9% by weight of 2-hydroxy-4-propenyloxyethoxybenzophenone. In one or more other embodiments, The polymeric composition comprises about 01% by weight of phthalocyanine blue. In one or more other embodiments, the polymerizable composition comprises about 0.3% by weight of a free radical initiator. In another particular embodiment, the polymerizable composition Containing 34% by weight of ω-bis(methacryloxyethylethylimidocarboxyethoxypropyl)-poly (二121842.doc 11 200817471 曱 矽 矽 )) (trifluoropropylmethyl decane)_poly(0)-methoxy-poly(ethylene glycol) propylmethyl decane), about 46% by weight &gt; 1 • Vinyl _N_ Methylacetamide, about 17% by weight of methyl methacrylate, about 5% by weight of ethylene glycol dimethacrylate, about i% by weight of allyloxy alcohol, about 9% by weight 2-hydroxy-4-propenyloxyethoxybenzophenone, about 1% by weight of phthalocyanine blue and about 0.3% by weight of 2,2,-azobisisobutyronitrile. In one embodiment, any one or more of the polymerizable compositions of the polyoxyalkylene oxide-free extractable components described herein are provided. In another aspect, a polymerizable combination as provided herein is provided. Hydrogenated hydrogel contact lenses produced by the substance. Hydroxyl hydrogel contact lenses formed from polymerizable compositions substantially free of extractable components as described herein are also provided. Also contemplated as part of the present invention is a rock oxide hydrogel contact lens produced by the following steps: polymerizing a polymerizable composition as provided herein to form a pre-extracted polymeric hemo-hydrogel comprising an extractable component Contact lenses, extractable components are extracted from pre-extracted contact lenses to form an extracted polymeric lens product, and the extracted polymeric lens product is hydrated to form a hydroxyl hydrogel contact lens. In one or more embodiments, the hydroxyl hydrogel contact lens produced as described above has an equilibrium water content in the range of from about 42% to about 50% by weight and is in the range of from about 80 to 110 barrer. Oxygen permeability ργίο·11). In one or more other embodiments, the hydroxyl hydrogel contact lens produced as described above has a modulus of from about 0.6 to about 1.2 MPa. In one or more other embodiments, the oxygenated water produced as described above is provided 121842.doc -12-200817471 The polymeric composition is heated to a gel contact lens wherein the polymerization step comprises a temperature which will be greater than about 65 °C. In another aspect, the equilibrium water content is provided at about 42 weights. a to about 50% by weight, oxygen permeability (1) in about 8 (M10 range, modulus is round to about. Milk, ion current is about 5 (xl〇mmVimn), advancing contact angle is about 52. to about 62., receding contact angle is about 40. to 60. and hysteresis is about 5. to about 15. Shishi oxygen hydrogel contact lens 0

钱 The one or more implementations of the money hydrogel contact lens as described herein are additionally characterized as a mirror body having a rounded peripheral edge. In one or more other embodiments, the 7 oxygen hydrogel contact lenses of the present invention can be: (1) spherical glasses, (9) aspherical glasses, (out) single focus glasses, (iv) multifocal glasses, or (v) rotation. Stable toric contact lenses. In one or more other embodiments, the Shixia oxygen hydrogel contact lenses of the present invention are in a sealed package. The Shixia Oxygen Hydrogel contact lens system provided in one or more other implementations has not been surface treated. In another aspect, provided herein is a method of producing a polymerizable silicone hydrogel contact lens precursor composition. In one or more embodiments, the method comprises a combination of heart-bis(methacryloxyethylethyliminocarboxyethoxypropyl)poly(monomethyloxane)-poly(trifluoro Propylmethyl decane) _ poly (1 - methoxy-poly (ethyl alcohol) propyl methyl oxiranane), Ν _ vinyl - Ν _ methyl acetamide methyl methacrylate, dimethyl Ethylene glycol acrylate, allyloxy alcohol and a free radical initiator to thereby produce a polymerizable oxime hydrogel cryptic 121842.doc-13-200817471 spectacles precursor composition. In one or more embodiments of the method, the combining step additionally includes an ultraviolet absorber. In one or more specific embodiments, the combining step additionally includes 2-hydroxypropenyloxyethoxybenzonitrile. In one or more other embodiments of the method, the combining step additionally comprises - a colorant, such as a phthalocyanine pigment, such as phthalocyanine blue. In one or more specific embodiments of the method, the free radical initiator is Γ) 2,2'-azobisisobutyronitrile. In one or more specific embodiments, the method comprises combining the following: (1) about 30% to about 4% by weight of α_ω_bis(mercaptopropenyloxyethyliminocarboethoxy) Propyl poly(didecyloxyl)-poly(trifluoropropylmethyloxirane)-poly(ω-methoxy-poly(ethylene glycol)propylmethyl decane), ( Ii) from about 40% to about 50% by weight of Ν-vinyl-indole-methylacetamide, (about 10% to 25% by weight of methyl methacrylate, and

U (IV) is less than about 5 by weight. /. Ethylene glycol dimethacrylate, allyloxy alcohol, 2-hydroxy-4-propenyloxyethoxybenzophenone, phthalocyanine blue and 2,2^ azobisisobutyronitrile combination. In one or more other embodiments of the method, the combining step comprises combining about 34% by weight of α-ω-bis(methacryloxyethyliminocarboxycarbonylpropyl)-poly (two Methyl oxy-oxygen)-poly(trifluoropropylmethyl-osinoxy)-poly(co-decyloxy-poly(ethyl-drug) propyl sulfhydryl oxy-combustion), about 46% by weight] ^_ vinyl-oxime-methylacetamide, about 17 weights of hydrazine/methyl methacrylate, about 121842.doc -14-200817471 0.5% by weight of ethylene glycol dimethacrylate, about 1% by weight of allyloxy alcohol, about 9% by weight of 2-hydroxyl-4-acryloxyethoxybenzophenone, about 0.1% by weight of phthalocyanine blue and about 0.3% by weight 2,2,-Azobisisobutyronitrile is used to thereby provide a polymerizable oxygenated hydrogel contact lens precursor composition. In one or more other embodiments, the method further comprises polymerizing the polymerizable lens precursor composition to form a pre-extracted polymeric oxygenated hydrogel contact lens. In one or more particular embodiments of the method, the polymerizing step comprises heating the polymerizable lens precursor composition. In one or more other embodiments, the method further comprises placing the ruthenium polymerization "glasses precursor composition" in a non-polar resin contact lens mold prior to the polymerization step. In - or a plurality of other embodiments, the method further comprises extracting the pre-extraction

Hydrogenated hydrogel contact lenses. In another 35 examples, provided herein is a hydroxyl hydrogel contact lens comprising substantially no extractable component reaction product as described herein. Polymerizable composition

It will be apparent from the above and following description that the two or both of the features, the examples of the composition and the method, and the scope of the claims are obvious. Each and every feature described herein and each and every combination of the above are included in the scope of the invention of the present invention. The limitation is that the features included in the combination are To. Furthermore, any feature or combination of features may be specifically excluded from any embodiment of the invention. Other aspects and advantages of the present invention are set forth in the following embodiments and claims. [Embodiment] The present invention will now be described more fully hereinafter. However, the present invention may be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein. Instead, the embodiments are provided so that this disclosure will be thorough and complete, and The scope of the invention. The singular forms "a" and "the" are used in the singular <RTI ID=0.0> </RTI> <RTIgt; </RTI> <RTIgt; </ RTI> <RTIgt; </ RTI> <RTIgt; </ RTI> <RTIgt; Glasses and two or more identical or different glasses, reference to &quot;precursor composition&quot; means a single composition and two or more identical or different compositions, and the like. And the following terms will be used in accordance with the definitions described below. As used herein, the term "hydrogel" refers to a polymer network or t-type that is typically capable of swelling or swelling in water. Polymeric. Network or base, port, $ or not. Hydrogel refers to a mouthwash that is swellable or expansive to water, including contact lenses. Thus, the hydrogel may (1) swell without being hydrated, or (1)) partially hydrated and swell with water, or (iii) fully hydrated and swell with water. 121842.doc -16- 200817471 The term "substituted" as in, for example, ''substituted alkyl'' refers to a moiety (eg, alkyl) substituted with one or more non-interfering substituents, such substitutions. Bases such as, but not limited to, CrC8 cycloalkyl (eg, cyclopropyl, cyclobutyl, and the like), yl (eg, fluoro, carbyl, bromo, and iodo), cyano, alkoxy, Low carbon phenyl, substituted phenyl and the like. For substitution on the phenyl ring, the substituents can be in any orientation (i.e., ortho, in between, or in pairs). The term &quot;hydrogenated hydrogel,&quot; or &quot;hydrogenated hydrogel material&quot; refers to a specific hydrogel comprising a bismuth (si) component or a bismuth component. For example, a hydroxyl hydrogel is typically It is prepared by combining a ruthenium-containing substance with a conventional hydrophilic hydrogel precursor. The oxime hydrogel contact lens is a contact lens comprising a silicone hydrogel material, including a contact lens for correcting vision. The characteristics of gel contact lenses are different from those of conventional hydrogel-based glasses. "The oxygen-containing component contains at least one [-Si-0-Si] bond in the monomer, macromer or prepolymer. a component wherein each hydrazine atom may have one or more organic group substituents which may be the same or different (Ri, D or substituted organic group substituents, for example, -SiRiR^O-. ''or ''as appropriate' means that the events described below may or may not occur 'so that this description includes the circumstances in which the event occurred and the event does not occur. In the case of the polymer of the present invention, Molecular mass &quot; refers to the nominal average molecular mass of a polymer, usually borrowed Size exclusion chromatography, light scattering technique or intrinsic velocity measurement in 1,2,4-tris benzene. The molecular weight in the case of a polymer can be expressed as a number average molecular weight or a weight average molecular weight, and The substance supplied by the manufacturer will depend on the supplier. If 121842.doc -17· 200817471 is not supplied in the form of a packaged substance, the basis of any such molecular weight determination can be easily provided by the supplier. The macromonomer: the molecular weight of the polymer herein refers to the weight average molecular weight. The molecular weight in the number average molecule and the weight average molecular weight can be measured using gel permeation chromatography or other liquid chromatography techniques. Other measurements can be used: sub-quantity methods such as end-group analysis or measurement-dependent (eg, descent drop 'boiling point rise or osmotic pressure) to determine the number average molecular size

或 Or use light scattering techniques, ultracentrifugation or viscosity measurements: denier average molecular weight. The hydrophilic polymer, network, or &quot;matrix&quot; generally means cross-linking formed by covalent bonds or physical bonds (e.g., hydrogen bonds) between polymer chains. Force = water ^ substance is a water-based substance. The compound has an affinity for water to give π or a polar side chain group with water attraction. "Monthmic hydrophilic polymer" is defined as a polymer that swells in water but is soluble in water. ..., ,, a hydrophilic component &quot; is a hydrophilic substance which can be or is a polymer. Pro == can be combined with the remaining reactive components to be able to hydrate the resulting =, at least about (for example at least about 2 - can be worn on a human &quot; hydrogel contact lens, refers to wearing on the human eye And people do not experience or report real stimulation and similar discomfort) 矽 oxygen k (including eyesight moonstone oxygen coagulation ... contact lenses. Eyes compatible with the eve milk mirrors often do not cause significant angular swelling, cornea Detachable surface wettability 'and dehydration of the lunate membrane (dry eye disease)), upper cornea 121842.doc -18- 200817471 epithelial arch lesion (&quot;SEAL") or other significant discomfort or related to these diseases. &quot;or" basically &quot; or &quot;about&quot; means that the stomach is almost all or completely, such as 95% or more of a certain given amount. &quot;Substantially non-existent&quot; or &quot;substantially no&quot; A feature or entity means that the feature or entity is substantially completely or completely absent, for example, containing 5% or less than 5% of a given entity. For example, a composition that is substantially free of an entity may contain Less than about 5% or less than about 4%, less than about 3%, less than about 2%, or at least About 1% of a given entity. ''Alkyl' refers to a hydrocarbon chain typically having a length in the range of from about 1 to 20 atoms. The hydrocarbon chains are preferably, but not necessarily, saturated, and although generally straight chain is preferred But may be branched or straight chain. Exemplary alkyl groups include methyl, ethyl, propyl, butyl, pentyl, 1 methylthio, i-ethylpropyl, 3·methylpentyl And a similar alkyl group. When referring to three or more carbon atoms, as used herein, ''alkyl group'' includes a cycloalkyl group. A π oligomer is a molecule composed of a finite number of monomeric subunits. And usually consists of from about 2 to about 8 monomeric subunits. π lower alkyl" means an alkyl group containing from 1 to 6 carbon atoms and may be straight or branched, such as methyl or ethyl. Other n-butyl, isobutyl, and tert-butyl groups. Other definitions can also be found in the following sections. Summary As set forth above, the invention provided herein is based, at least in part, on the following findings/formulations, ie, Avoid problems associated with polar resin molds, avoid the need for complex and expensive post-polymerization procedures, and resolve and polymerize 121842.doc -19- 200817471 Method of humectant IPN related problems to prepare an eye-compatible shixi oxygen hydrogel contact lens. Furthermore, the formulation provided herein does not require more than about 30% of the removable or extractable component, the group The fraction is substantially unincorporated into the polymerized hydrogel contact lens product and is removed from the resulting molded contact lens product by extraction with other unreacted components. For example, compatible oxygen on the eye. The hydrogel contact lens can be self-extracted polymeric helium oxygenated with an extractable inclusion of at least 1% and less than about 30% of the dehydrated extracted hydroxyl hydrogel contact lens as discussed herein. Obtained from the contact lens product. In certain embodiments, the lens formulation is free of polyoxyalkylene oxide components. In particular, a method of producing an eye-compatible oxygenated hydrogel contact lens comprises incorporating a particular combination of components into a polymerizable silicone contact lens precursor composition. The materials impart the desired characteristics to the resulting final contact lens to provide an extracted contact lens product which is then hydrated to produce a final enamel having an ophthalmically acceptable surface wettability and other beneficial characteristics as described herein. Oxygenated Hydrogel Contact Lenses are described in detail in the following sections and illustrate such and other important aspects of the present invention. Component of Polymerizable Hydroxyl Hydrogel Contact Lens Precursor Composition The hydroxyl hydrogel contact lens of the present invention is generally referred to herein as a polymerizable silicone hydrogel contact lens precursor composition or "precursor" The composition of the body composition π is produced. For example, the body composition is a mixture of various agents used to prepare a helium oxygen hydrogel contact lens, i.e., a reaction mixture prior to the reaction (polymerization in the context of the present invention). 121842.doc -20- 200817471 The precursor composition of the present invention generally comprises at least the following components: α_ω bis(mercapto propylene methoxyethyl imino carboxy ethoxy propyl) _ poly (dimethyl oxime) Alkyl)-poly(trifluoropropyldecyloxyl)-poly(ω_methoxy-poly(ethylene glycol)propylmethoxine), Ν_vinyl_N_f-acetamide, f Acrylic acid methyl vinegar, ethylene glycol methacrylate, allyloxy alcohol and a free radical initiator. In certain embodiments, the composition consists essentially of the foregoing components. In other embodiments, the composition consists entirely of the foregoing components.

Ο — bis(methacryloxyethyl imino carboxy ethoxypropyl) poly(didecyl fluorene oxide)-poly(trifluoropropylmethyl decane) _ poly((〇甲Oxypoly (ethylene glycol) propyl methyl oxirane) The first component of α-ω-bis(methacryloxyethylethylimidocarboxyethoxypropyl)-poly(dimethyl矽 烷)-poly(trifluoropropylmethyl decane)-poly(ω-methoxy-poly(ethylene glycol) propylmethyl decane) is a reactive fluoropropenyl hydrazine The macromonomer, commonly known as "M3U," (CAS Accession No. 697234_74_5). As shown in the general structure below, the macromonomer is a triblock copolymer, ie containing three different siloxane polymers. The central block has a trifluoromethyl substituent and the acryl fluorenyl moiety is present at each end.

Ch2c HsCFs ΟΗ2ΟΗ2〇Η2(ΟΟΗ2ΟΗ2)ρΟΟΗ3 〇 /CH3 -(〇Η2)30 (ch2)』ch3

I is continuous with the downstream structure -Si—0 CH, o continued -Si ΟΙ CH3

Sj-〇 ChU

Si ch3 NH(CH2)2〇C-CH3 : CH〇121842.doc -21 - 200817471 The variables η, m and h correspond to the number of repeating units of each block, and each independently ranges from about 3 to about 200. And p (the number of ethylene oxide repeating units) is in the range of from about 2 to about 12. A particularly preferred macromonomer corresponding to the above structure is a macromonomer in which η is in the range of 50 to 200, ruthenium is in the range of 5 Å, and h is in the range of 1 to 15. In a particularly preferred embodiment, η is about 121, m is about 7.6, h is about 4.4, and p is about -7.4. The M3U can be easily synthesized according to the procedure set forth in Example 1 of International Patent Publication No. WO 2006/026474. Ο Depending on the values of the variables n, m, h and p, the molecular weight of the oxime macromonomer component (ie M3U) is typically in the range of from about 8,000 daltons to about 25,000 daltons. And preferably in the range of from about 10,000 Daltons to about 2 inches, and Dalton. A particularly preferred oxygenated macromolecular monomer for use in the present invention has a molecular weight of about 16,000 Daltons. For example, the macromonomer can have a weight average molecular weight (mw) of about 16,200 Daltons and a number average molecular weight (?n) of about 12,800 Daltons. The polymerizable silicone hydrogel precursor compositions provided herein typically comprise at least about 25% by weight of cardio-bis(methacryloxyethyliminocarboxycarbonylpropyl)-poly (dimethyl oxalate)-poly(trifluoropropylmethyl oxynoxy) _ , poly(ω-methoxy-poly(ethylene glycol) propylmethyl decane), and more Preferably containing at least about 30% by weight of α-ω-bis(methacryloxyethyl iminocarboxyethoxypropyl)-poly(dimethyloxane)-poly(trifluoropropyl A)矽 矽 ) _ _ poly (ω-methoxy-poly (ethylene glycol) propyl methyl oxirane). Even more preferably, the polymerizable composition of the present invention contains from about 25% by weight to about 40% by weight of α-ω-bis(methacryloxyethyliminocarboxycarbonylpropyl)-poly(二曱121842.doc -22- 200817471 矽 oxane)-poly(trifluoropropylmethyl decane)_poly(ω_methoxy-poly(ethylene glycol) propylmethyl decane) Or preferably containing from about 30% by weight to about 4% by weight of α-ω-bis(methacryloxyethyliminocarboxycarbonylpropyl)·poly(dimethyloxane) _ poly(trifluoropropylmethyl decane) _ poly (〇 _ methoxy _ poly (ethylene glycol) propyl methyl oxime). A particularly preferred polymerizable combination comprises about 34 weight percent. Α-ω-bis(methyl propyl methoxyethyl imino carboxy ethoxy propyl poly (dimethyl methoxy oxane) - poly (trifluoropropyl methyl oxirane) - Poly(ω-decyloxy-poly(ethylene glycol) propylmethyl decane). (^ 乙·Ethylene-fluorene-methyletheneamine. The polymerizable composition as provided herein additionally contains hydrazine. -vinylmethylacetamide (VMA), a hydrophilic vinyl-containing (ch2=CH-) monomer. The structure of VMA corresponds to CH3C(0)N(CH3)-CH=CH2. Other hydrophilic vinyl-containing monomers in the materials of the glasses include the following: N-ethylene decylamine (for example, N-ethylene σ than acetophenone (ΝΫΡ)), Ν_vinyl Ν -ethyl acetamide, hydrazine-vinyl-hydrazine-ethyl decylamine, hydrazine-vinyl carbamide, hydrazine hydrazide 2 - hydroxyethyl vinyl vinegar, hydrazine - ^ carboxy-β-alanine bismuth - Vinyl ester. The ruthenium-vinyl-oxime-mercaptoacetamide is preferably present in an amount ranging from about 35 weight percent to about 55 weight percent of the precursor composition used to prepare the as-receiving lens product. In the polymeric composition, and even more preferably from about 40% to about 50% by weight The amount in the range of the body composition is present. The representative weight of the Ν-ethylene-fluorene-methyletheneamine comprises the following weights: about 40% by weight, 41% by weight, 42% by weight, 43% by weight, 44 % by weight, 45% by weight, 46% by weight, 47% by weight, 48% by weight, 49% by weight or 50% by weight of the precursor group 121842.doc -23-200817471. In a preferred embodiment, as herein The polymerizable composition provided comprises about 46% by weight of N-vinyl-N-mercaptoacetamide. Methyl methacrylate (MMA) is useful for preparing the hydroxyl hydrogel contact lens product of the present invention. The polymeric precursor composition additionally comprises an acrylic monomer, such as methyl methacrylate. The methyl methacrylate is preferably used in an amount of from about 10% by weight to about 25% by weight to prepare the hydrogenated hydrogel lens product. The amount within the range of the bulk composition is present and is even more preferably present in an amount ranging from about 10% to about 22% by weight of the precursor composition. Representative of methacrylate vinegar as a whole precursor formulation Weight percentages include the following weight percentages: approximately 1 weight 11% by weight, 12% by weight, 13% by weight, 14% by weight, 15% by weight, 16% by weight, 17% by weight, 18% by weight/❶, 19% by weight, 2% by weight, 21% by weight, 22% by weight %, 23% by weight, / 24% by weight, and 25% by weight of bismuth dimethacrylate (EGDMA) precursor composition additionally comprising an acrylate functionalized ethylene oxide oligomer, i.e. having about i to Approximately 8 consecutive ethylene oxide (CH2CH2(R)·) monomer subunits and an ethylene oxide oligomer functionalized with a reactive group such as an acrylate acrylate. The acrylate functionalized ethylene oxide oligomer is preferably an oxyethylene monomer or a monomer and is homobifunctional, i.e., terminated at each terminal by a methacrylate group. A general structure is provided below, wherein the variable s corresponds to the number of ethylene oxide monomers. 121842.doc -24- 200817471 c=r / \ / C\C, H2CH2)S'丫 II 〇 o In the above structure, S is generally between 丨 and about 8, preferably 丨 to about 4. That is, preferred values of s include i, 2, 3, 4, 5, 6, 7, and 8. The propylene oxide polymer to be functionalized by propylene is preferably an oxyethylene dimethyl acrylate wherein s has a value of 1. Acrylic acid acrylate oligomers (i.e., egdma) are typically present in the precursor composition in a small amount. For example, the oligomer is present in the precursor composition in an amount ranging from about 0.05% to about 10% by weight, preferably from about 75% by weight to about $% by weight. The representative amount of the leg component includes the following amounts: about 1% by weight, 0.2% by weight, 0.3% by weight, 4% by weight, 1% by weight, 1% by weight, 〇·8 by weight. /❶,〇 9 wt%, 1 weight. /. 2 weight. /〇, 3% by weight, 4% by weight or 5% by weight of the precursor composition. In the preferred embodiment, the precursor composition of the present invention comprises about 5% by weight of EGDMA decyl allyloxy alcohol. In addition to the above, the polymerizable composition of the present invention comprises a chain transfer agent. ΜTransfer 3d is a compound which promotes the reaction between a radical substance and a non-radical substance, and is preferably used in the chain transfer agent of the present invention as a fluorenyloxy compound, a compound of 卩匕3 or an allylicoxy moiety. . Examples of this type τ [The raw chain transfer tanning agent includes allyloxy alcohol. The chain transfer agents can be used individually or in the form of a mixture. The compound having an allylicoxy moiety has the following generalized structure 121842.doc -25- 200817471 constituting h2c: /CH2 *CH \ .

··· °rQ where the box portion corresponds to the p-propoxy moiety, residue or residue, such as Q, if the parent is not a parent, or if any of the organic small members are connected together, It is preferred to derive from the formula with allyloxy alcohols such as ethanol, propanol, butanol and =. Q is preferably a residue of ethanol, and has: or a substituted form thereof, such that it is effective (including (3), as the inventors have discovered, including chain transfer agents (such as dilute propoxy compounds) An extracted hydrated xenon contact lens body having reduced variability in size and physical properties is provided. Therefore, 'adding a chain transfer agent to &quot;normalize&quot; or &quot;fine tune&quot; precursor lens composition to obtain the resulting extracted The hydrated contact lens population typically has reduced variability between batches of any one or more of the following characteristics: equilibrium water content, oxygen permeability, static contact angle, dynamic contact angle (forward contact angle or receding contact angle) 'lag, Refractive index, ion current, modulus, tensile strength, and the like. As used herein, a batch or group system refers to a plurality of contact lenses. It is understood that the number of contact lenses in a contact lens batch or population is sufficient to provide meaningful A modified statistical value is achieved in the standard error. In some cases, a batch of contact lenses refers to at least 10 contact lenses, at least 1 contact lens, to 1 contact lens or more. In general, the polymerizable composition as provided herein contains about 0.1 weight of 121842.doc -26-200817471 η (four) amount of diloxypropanol. Preferably, the composition contains from about 0.5% by weight to about 3% by weight of allyloxy alcohol. That is, the polymerizable composition preferably contains the following exemplary allylic alcohol (such as allyloxyethanol). Any of the weight percentages: 〇1, 〇2, 〇3, 〇4, 0.5, 0.6, 0.7, 0.8, 0.9, !, !", 1 2, ι 3, ι 4 ... 2.7, 2.8, 2.9 or 3% by weight. Free radical initiatorΟ

In addition to the above, the precursor compositions of the present invention typically comprise one or more initiator compounds, i.e., compounds capable of initiating polymerization of the precursor composition. Preferably, it is a thermal initiator, that is, an initiator having a polymerization initiation temperature. It is possible to reduce the ions of the glasses of the present invention by selecting a thermal initiator having a higher initial decomposition temperature and using a relatively small amount of an initiator. Flow, whereby the amount of removable material removed or extracted during the extraction step can be affected. For example, an exemplary thermal initiator that can be used for σ is VAZO® _ 64, which corresponds to 2, 2, azo Diisobutyronitrile (AIBN), available from Dup〇nt (Wilmington, DE). All of the VAZ〇9 thermal initiators described herein are available from DuPont (Wilmington, DE) and are suitable for use in the compositions provided herein. The VAZO® thermal initiator is a substituted azonitrile compound which is thermally decomposed to produce two free radicals per molecule. The half-life of VAZO®-64 solution at 64 ° C is 10 hours. The number of stages (e.g., "64" in the foregoing examples) corresponds to the Celsius temperature at which the solution has a half-life of 10 hours. Other VAZO® initiators suitable for use in the compositions provided herein include 2,2'-azo Bis(2,4-dimethylvaleronitrile) (VAZO®-52), 2,2,-azobis 1 21842.doc -27- 200817471 (2-methylpropionitrile) (VAZO®67) and azobisisobutyronitrile (VAZO8-88). VAZO®-52 has an initial decomposition temperature of about 50 °C, while VAZO® _88 has an initial decomposition temperature of about 90° C. Other thermal initiators suitable for use in the polymerizable composition include nitriles such as 1,1'-azobis(cyclohexanecarbonitrile) and 2,2,-azobis. (2-Methylpropionitrile) and other types of initiators, such as those purchased from Sigma Aldrich. • Eye-compatible, oxygenated hydrogel contact lenses can contain from about 5% by weight to about 1.0% by weight. % or preferably obtained from a precursor composition of from about 7 wt% to about 7 wt%/❻ of a free D-based initiator such as one of the above-mentioned VAZO® initiators. The precursor composition described herein preferably contains about 0.07, 0.08, 0.09, 0.1, 〇2, 0.3, 0.4, 0.5, 0.6 or 〇·7 wt% of a free radical initiator. Hydroxyl hydrogel contact lenses Additional Components of the Precursor Composition The ophthalmic composition of the present invention may also include additional components such as ultraviolet (UV) absorbers or UV radiation. Or an energy absorbing agent and/or a coloring agent. The UV absorbing agent can exhibit a relatively high absorption value, for example, in the range of UV-A of about 320-380 nm, but is relatively transparent at about 380 nm or more. Υν Absorbent. Examples include photopolymerizable hydroxydibenzophenone and photopolymerizable. Benzotriazole, such as 2·hydroxy-4-propenyloxyethoxybenzophenone (purchased with CYASORB® UV416) From Cytec Industries), 2-based 4-(2-propenyl-3·mercaptopropyloxy)propoxybenzophenone and photopolymerizable benzotriazole (from Norramco® 7966 from Noramco) ). Other photopolymerizable UV absorbers suitable for use in the present invention include polymerizable ethylenically unsaturated triterpenes, salicylates, aryl substituted acrylates, and mixtures thereof. In general, 121842.doc • 28-200817471, the UV absorber, if present, is provided in an amount corresponding to from about 5% by weight of the precursor composition to about 1.5% by weight of the composition. Particularly preferred are compositions comprising from about 0.6% by weight to about 1% by weight of the UV absorber. The illustrative composition may contain, for example, about 5% by weight, 0.6% by weight, 〇.7% by weight, 0.8% by weight, 〇·9% by weight, 1.0% by weight, 1.1% by weight, 1.2% by weight, 1.3% by weight, 1.4% by weight or about 1.5% by weight of 11 乂 absorbent. The precursor compositions of the present invention may also include colorants, although encompassing colored eyeglass products and clear lens products. The colorant is preferably a reactive dye or pigment that effectively provides color to the resulting lens product. The reactive dyes are dyes that are bonded to the oxygenated hydrogel lens material and do not bleed. Exemplary colorants include the following: benzenesulfonic acid, 4-(4,5-dihydro-4-((2-methoxy-5-methyl-4-((2-(sulfooxy))) (sulfonyl)sulfonyl) azo-3.methyl-5-o-oxy-1H-pyrazol-1-yl); [2-naphthalenesulfonic acid, 7-(ethinyl)-4 -hydroxy-3-((4-((sulfooxyethyl))sulfonyl)phenyl)azo)-]; [5-((4,6·dichloro-1,3,5·triazine) _2_yl)amino-4-hydroxy-3-((1-sulfo-2-naphthyl)azo-2,7-naphthalene-disulfonic acid, trisodium salt]; [copper, 29H, 31H_ Phthalocyanine (2_)-&gt;129, 仏(),&gt;131,:^32)-, sulfo((4((2-sulfo)oxy)))))))) Sulfhydryl derivative] and [2,7-naphthalenesulfonic acid, 4-amino-5-hydroxy-3,6·bis((4-((2)(sulfooxy)ethyl) fluorenyl)benzene Azob tetrasodium salt]. Particularly preferred colorants for use in the present invention are phthalocyanine pigments such as phthalocyanine blue and phthalocyanine green, chromium oxide-alumina-cobalt oxide, chromium oxide, and red, yellow. , a variety of iron oxides of brown and black. In general, if used, the colorant will comprise from about 5% by weight to about 5% by weight of the composition, or Preferably, the composition comprises from about 7% by weight to about 3% by weight of the composition. The illustrative weight percentages of the colorant (for example, phthalocyanine 121842.doc -29-200817471 pigment) include the following weight %: 〇〇5 weight %, 0.06 weight 1% '〇〇7 wt%, 〇〇8 weight. 〇〇9 wt%, heavy 〇·2 weight%, 〇_3 wt%, 〇·4 wt%, 〇·5 wt% and Similar to bismuth. Opaque agents such as titanium dioxide may also be incorporated. For some applications, a mixture of colors may be used to better simulate the appearance of a natural iris. A representative precursor composition comprises about 3 〇 weight 。 / to 4 〇% by weight of heart _ 'bis(methacryloxyethyl iminocarboxyethoxypropyl)-poly(dimethyloxane)-poly(trifluoropropylmethyloxyl) _ poly ((〇 曱 曱 - - - - - - ) ) 、 、 、 、 、 约 约), about 40% by weight to 50% by weight of vinyl-N-methyl acetamide, about丨〇% by weight to 25% by weight of methyl methacrylate and less than about 5% by weight of ethylene glycol dimethacrylate, allyloxy alcohol, 2-hydroxy- A combination of 4-propenyloxyethoxybenzophenone, phthalocyanine blue and 2,2,-azobisisobutyronitrile, ie by combining the above components. Exemplary precursor composition provided In Example 1. In a particularly preferred embodiment, the polymerizable composition can comprise, consist essentially of, or consist of the following amounts (in % by weight): about 34 weight 0/ 〇ί ) ^ α·ω-bis(methacryloxyethylethylimidocarboxyethoxypropyl)-poly(dimethyloxane)-poly(trifluoropropylmethyloxime) Alkyl)-poly-p-methoxy-poly (ethylene glycol) propyl sulfhydryl), about 46% by weight of ^-ethyl decylmethyl acetamide, about 17% by weight of methyl propyl Dilute decyl ester, about 5 wt%/〇 of ethylene glycol dimethacrylate, about 1% by weight of diloxypropoxy alcohol, about 0.9% by weight of 2-hydroxy-4-propenyloxy B Oxybenzophenone, about 1% by weight of phthalocyanine blue, and about 0.3% by weight of 2,2'-azobisisobutyronitrile. Some embodiments of the oxime composition of the present invention include a polymerizable shiheyl hydrogel contact lens precursor composition provided in a non-polar resin occlusion 121842.doc • 30-200817471 eyeglass mold. Other embodiments include such compositions in storage containers such as bottles and the like, or in dispensing devices such as manual or automatic pipetting devices. ° Method of forming oxygenated hydrogel contact lenses As in the case of producing Shishi oxygen hydrogel contact lenses, the components of the Shixi oxygen hydrogel contact lens precursor composition are each weighted and combined. The carrier typically mixes the resulting precursor composition, e.g., using magnetic or mechanical mixing, and optionally filters to remove particulates. The spectacles of the present invention can be produced, for example, as illustrated in circle j.囷 1 is a block diagram illustrating a method of producing a helium oxygen hydrogel contact lens. In particular, Figure 1 illustrates a method of casting a silicone hydrogel contact lens. The cast contact lens can itself be produced in a form suitable for direct placement on the human eye without the need for further processing to modify the lens to make the lens suitable for use on the eye. The hydroxyl hydrogel contact lens of the present invention produced by a wash molding procedure such as that illustrated in Figure 1 is herein considered to be &quot;casting a hydrogel contact lens&quot;. The eyeglasses of the present invention are understood to be ''completely formed silicone hydrogel contact lenses') without the use of processing to modify the eyeglass design that causes the eyeglass product to be removed from the mold member. Illustrative methods for producing contact lenses, such as neohydrogenated hydrogel contact lenses, are described in at least the following patents: U.S. Patent Nos. 4,121,896, 4,495,313, 4,565,348, 4,64, 489 No. 4,889,664 第, 4,985,186, 5,039,459, 5,080,839, 5, 〇94,609, 5,260,000, 5,6〇7 518, 5,76〇1〇〇121842. Doc-31-200817471, 5,850,107, 5,935,492, 6,099,852, 6,367,929, 苐6,822,016, 6,867,245, 6,869,549, 6,969,487, and U.S. Patent Publication No. 20030125498, 20050154080 and 20050191335. . . . Α V 5兀&quot; 々Ο 々Ο Ο method includes the step 102 of placing a polymerizable silicone hydrogel lens precursor composition (202, as shown in Figure 2) Contact lens mold member on or inside. The polymerizable oxalate hydrogel lens precursor composition refers to a prepolymerized or precured composition suitable for polymerization. The polymerizable composition of the present invention as used herein may also be referred to as "monomer mixture, or, reaction mixture". The polymerizable composition or lens precursor composition is preferably not polymerized to any significant extent prior to the combination 2 curing or polymerization. However, in some cases, the polymerizable composition or lens precursor composition can be partially polymerized prior to being subjected to curing. Prior to the curing or polymerization procedure, the lens composition of the present invention can be supplied to a container, a dispensing device or a contact lens mold. Go back to 囷1, step 1 〇2, and the eyeglass precursors are P 曰 曰 、, and. The object is placed in a concave invisible frog mirror member to form an off-surface contact lens mold member. ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ The first contact lens mold member of the contact lens produced by the reduction lens and the contact lens mold that is placed in contact with the first embodiment to form the contact lens-like cavity 1 includes a contact lens mold member contacting the contact lens mold member . Therefore, 隐, that is, the contact lens mold is closed by placing the two contact lens molds 121842.doc • 32 · 200817471 in contact with each other to form a contact lens-like cavity. The polymerizable oxalate hydrogel lens precursor composition 202 is located in a contact lens shaped cavity. The second contact lens mold member refers to a convex invisible eye mold member or a rear contact lens mold member. For example, the second contact lens mold member includes a lens forming surface that defines a rear surface of the contact lens produced in the contact lens mold. Ο ί) "Non-polar resin contact lens mold" or "hydrophobic tree opening" &gt; glasses mold" as used herein refers to a contact lens mold formed or produced from a non-polar or hydrophobic resin. Therefore, non-polar The resin-based contact lens mold may comprise a non-polar or hydrophobic resin. For example, the contact lens molds may comprise one or more polyolefins or may be formed from a polyolefin resin material. Non-polar for use in the context of the present application. Examples of resin contact lens molds include polyethylene contact lens molds, polypropylene women contact lens molds, and polystyrene contact lens molds. Non-polar resin based contact lens molds typically have a hydrophobic surface. For example, if a trapping bubble method is used It is determined that the non-polar resin mold or the hydrophobic resin mold may have a static contact angle of about 90. or more. At these contact angles, the conventional broken oxygen hydrogel contact lenses produced in the molds have clinical properties. Unacceptable surface wettability: Side: further comprising curing 106 polymerizable oxime hydrogel lens precursor composition Forming a pre-extracted polymeric helium oxygen anger m 7 虱 hydrogel contact lens product L 2 as shown in the person) ° during the curing period, 'polyoxygenated hydrogel glasses = body two: the glasses forming component polymerization Forming a polymeric lens product. Also understood as a polymerization step. Curing 1〇6 may include exposing the polymerizable eyeglass composition to radiation, such as heat radiation or any basin 121842.doc-33-200817471 For example, the composition of the composition of the body composition. For example, the curing 106 can include exposing the polymerizable lens precursor composition to heat or ultraviolet (UV) light in the polymerization. The curing can be carried out in an oxygen-free environment as the case may be. For example, a, curing can be carried out under an inert atmosphere (eg, under nitrogen, argon, or other inert gas). In a particular embodiment, curing comprises, as is known herein, heating the polymerizable composition to greater than about The temperature of 5 5. The pre-extracted polymeric hydrogel contact lens product 2〇4 refers to the polymerized product of the extraction procedure subjected to the removal of substantially all of the removable/extractable components from the polymerized product. Contact with the extraction composition Previously, pre-extracted polymeric hydrogel contact lens products can be provided on or in contact lens molds, extraction trays, or other devices. For example, after the curing process, pre-extracted polymeric oxygenated hydrogel contact lenses The product may be provided in the lens-like cavity of the contact lens mold; after the contact lens mold is released, it may be provided on or inside the seed lens mold member; or after the mirror removal procedure and at: Can be provided on or in the extraction tray or other device. The pre-extracted polymeric oxygenated hydrogel contact lens product comprises a lens forming component (such as a spectacles-containing network or matrix) and can be formed from glasses. The removable component is removed from group 7. The removable component includes unreacted monomer, oligomeric monomer, or other agent that is not covalently linked to the lens forming component. The removable component can also include one or more additions 4: including organic additives, including diluents, which can be extracted from the polymeric lens product during the extraction, as discussed previously. Thus, linear uncrosslinking, cross-linking and/or fractionation 121842 may be included in the removable group, including extractable materials that are gas or fixed relative to the polymer backbone, network or matrix of the lens body. Doc -34- 200817471 Branch polymer. Additionally, the removable component can include other materials, such as volatile materials, that can be passively or actively removed from the pre-extracted polymeric hydrogel contact lens product prior to extraction. For example, a portion of the removable component can be evaporated between the demolding step and the extraction step. After the colloidal polymerizable lens precursor composition is applied, the release lens 108 of the contact lens is performed. Demolding refers to the method of separating two mold members (such as male and female mold members) of a mold or polymerization apparatus containing a pre-extracted polymeric contact lens product. The pre-extracted polymeric hemohydrogel contact lens product is located on one of the demolded mold members. For example, the polymeric oxygenated hydrogel contact lens product can be located on a male mold member or a female mold member. The pre-extracted polymeric oxygenated hydrogel contact lens product 204 is then separated from the contact lens mold member it is positioned during the mirror removal step 110 (shown in Figure i). The pre-extracted polymeric contact lens product can be removed from the convex mold member or the female mold member depending on the mold member that the polymeric contact lens product remains adhered during the release of the contact lens mold. After the pre-extracted deoxyhydrogel contact lens product is demired, the method includes extracting 112 extractable material from the pre-extracted neohydrogen hydrogel contact lens product. Extraction step 112 results in an extracted oxygenated hydrogel contact lens product 206 (shown in Figure 2). Extraction step 112 refers to the process of contacting the pre-extracted polymeric hydrogel contact lens product with one or more extraction compositions, and may include a single extraction step or several sequential extractions. For example, a poly-stone water-breaking gel-like eyeglass product or a batch of polymeric hydrogenated hydrogel invisible eye 121842.doc -35- 200817471 The mirror product is contacted with one or more volumes of liquid extraction medium. The extraction medium typically includes one or more solvents. For example, the extraction medium includes ethanol, methanol, propanol, and other alcohols. The extraction medium may also include a mixture of an alcohol and water, such as a mixture of 50% ethanol and 50% deionized water, or a mixture of 7% ethanol and 30% deionized water, or 9% ethanol and 1% deionized water. a mixture of water. Alternatively, the extraction medium can be substantially or completely alcohol free, and can include an agent that facilitates removal of the hydrophobic unreacted component from the Iwate hydrogel lens product. For example, the extraction medium can comprise, consist essentially of, or consist entirely of water, a buffer solution, and the like. Extraction 112 can be carried out at various temperatures, including room temperature. For example, the extraction can occur at room temperature (eg, about 20 Torr, or it can occur at elevated temperatures (eg, about 25 Torr to about 1 〇〇c). Further, in certain embodiments, the extraction step This may include contacting the lens product with a mixture of alcohol and water, and in some cases, may comprise the final step of a multi-step extraction procedure. Extracting the pre-extracted polymeric hydrogel contact lens product to provide an extracted polymerization After the oxygenated hydrogel contact lens product, the method comprises hydrating 114 the extracted polymeric oxygenated hydrogel contact lens product. The hydrating step 114 can comprise, for example, subjecting the extracted polymeric hydrogel hydrogel contact lens product or one or The plurality of batches of the products are contacted with water or an aqueous solution to form a hydrated oxalate hydrogel contact lens 208 (as shown in 囷 2). For example, the extracted polymeric oxime hydrogel contact lens product can be placed by Hydrating in two separate volumes or in two separate volumes of water, including deionized water. In some embodiments, the hydrating step 114 is combined with the extraction step ι12 to enable the two steps in contact lens production. The hydration step 114 can be carried out at room temperature or elevated temperature and, if necessary, under high pressure in a volume of 121842.doc -36 - 200817471. For example, the hydration can be at about 120 ° C (eg The temperature of 1212⁄4) and the pressure of 1〇3 kPa (15 pSi) occur in water. Therefore, as apparent from the above, it is considered that the pre-extracted polymeric rock-oxygen hydrogel contact lens product and the extracted polymeric hydrogen peroxide water are considered. The gel contact lens product is a product or component of water swellability and is considered to be invisible to the hydrated hydrogel. • The spectacles are water swellable products or components. As used herein, oxime hydrogel shaped glasses refer to The Shixi oxygen hydrogel component undergoing the hydration step. Because of this P Shixia Oxygen/Glue contact lens can be a fully hydrated Shixia oxygen gel contact lens, a partially hydrated hydrogel contact lens or dehydrated Oxygenated hydrogel contact lenses. Dehydrated hydrogel contact lenses are contact lenses that have undergone hydration and have been dehydrated to remove water from the glasses after hydration. Contact lens products to produce 矽After the hydrogel contact lens, the method includes the step 116 of encapsulating the oxygenated hydrogel contact lens 208. For example, the helium oxygen hydrogel contact lens 2 can be placed in a volume including a liquid (such as a physiological saline solution). In a blister pack or other suitable container, including a buffered physiological saline solution. Examples of liquids suitable for the spectacles of the present invention include phosphate buffered physiological saline and shed acid buffered physiological saline. Show, then seal the blister pack or container' and then sterilize. For example, the encapsulated oxaxy hydrogel contact lens can be treated, for example, by autoclave treatment, gamma light shot, electron beam stimuli or ultraviolet radiation. Exposure to sterilizing radiation, including thermal radiation. Characteristics of Hydroxy Hydrating Glasses As discussed above, the compositions and methods provided herein provide for the upper phase of the eye 121842.doc -37- 200817471 Glue contact lenses. The pre-extracted polymeric oxime hydrogel ophthalmic product is extracted and hydrated to form a shixi oxygen hydrogel contact lens having an ophthalmically acceptable surface wettability. The spectacles of the present invention have oxygen permeability, surface wettability, modulus, water content, ion flow, design, and combinations thereof, which make the spectacles of the present invention suitable for comfortable stretching of the patient's eyes, such as at least one day, at least One week, at least two weeks, or about one month, without removing the glasses from your eyes. As used herein, an oxygen-based hydrogel contact lens on the eye, which refers to a helium-oxygen gel that can be worn on the human eye without human experience or substantial discomfort (including eye irritation and similar discomfort). Contact lenses. Compatible with the eyes Ο

Hydroxyl hydrogel contact lenses have an ophthalmically acceptable surface wettability and generally do not cause significant corneal swelling, corneal dehydration (&quot;dry eye disease,), upper corneal epithelial arch lesion (&quot;SEAL") or显 He is significantly uncomfortable or unrelated to these conditions. The Oxygen Hydrogel Contact Lens with Ophthalmically Acceptable Surface Wetability means that the tear film of the eye of the wearer of the lens will not adversely affect the lens. The wearer experiences or reports the Shiyue Oxygen Hydrogel contact lens with the degree of discomfort associated with placing or wearing 7 oxygenated contact lenses on the eye. The eye-compatible Shishi milk gel contact lens meets for each Clinically acceptable requirements for wearing or long-term wear of contact lenses. The invention of a spectroscopy hydrogel contact lens comprises a lens body having a surface wettable (0ASW) surface with an ophthalmic fork, such as before The surface and the second table can be used for the hydrophilicity of the surface of the money-shaped glasses or the surfaces of the plurality of surfaces. In the second method, if the glasses are scored on the 3 乂 in the wettability test as follows, the glasses can be considered as glasses. The surface is wettable, or 121842.doc &gt;38- 200817471 Γ Ο for its eye-acceptable wettability. The contact lens is immersed in distilled water to remove it from the water and the length of time it takes for the water film to recede from the surface of the lens (eg water) Dispersion time (water Βυ or WBUT). The test provides the level of glasses in the linear range of Bu 10, where 10 points refers to the glasses in which the water droplets need 20 seconds or more to retreat from the glasses. Although (4) the in vitro evaluation of listening only Is a method or indication for QASW, but it can be considered that a hydrothermal gel contact lens having a water BUT of (10), above (such as at least 10 seconds or more preferably at least about 5 seconds) is ophthalmically acceptable. Surface wettability. Alternatively, OASW can be evaluated in vivo. If the eyeglasses can wear at least 6 on the patient's eyes and the person does not report discomfort or irritation, then the glasses are considered to have a dose. The contact angle on one or both of the glasses is measured to determine the contact angle. The contact angle can be a dynamic or static contact angle. A lower contact angle generally refers to an increase in the wettability of the contact lens surface. For example, a stone as provided herein. Xi The wettable surface of the oxygen hydrogel contact lens can have less than about %. The contact angle H is used in some (four) of the glasses of the present invention, the lens has a contact angle of 0; and in other embodiments, the present invention The hydroxyl hydrogel contact lens has a thickness of less than about 75. and even more preferably less than about 70. In the prior embodiment, the lens has a pre-contact angle in the range of from about 52 to about 62. The oxygen hydrogel (four) material mirror comprises a mirror body having (4) an acceptable surface: wettability. For example, the stone-oxygen hydrogel contact lens body of the present invention generally has a front surface and a rear surface, each surface having an eye The surface wettability of the tangible text is used. In the embodiment, the mirror body of the (4) hydrogel contact lens comprises Shi Xi oxygen water 121842.doc -39- 200817471 Γ Ο (4) The object f ° mirror body has no more than before extraction The dry weight of the mirror body is heavy. For example, the mirror body of the pre-extracted poly-cut oxygen hydrogel contact lens product may have a dry weight χ ° extraction procedure after the 'extracted poly-cut oxygen hydrocoagulated knee contact lens product has a mirror body of less than or equal to 09 Χ Dry weight. As discussed above, during the extraction step, the pre-extracted poly-cut oxygen hydrogel contact lens product can be contacted with a wide variety of organic solvents, followed by a hydration step to produce Dream Oxygen (tetra) shaped glasses. Next, the hydrated Wei hydrogel contact lenses were dehydrated and weighed to determine the dry weight of the lens body of the hydrogenated hydrogel contact lenses. By way of example, in some methods, the pre-extracted # 石 氧 氧 hydrogel contact lens product is unmirror from the contact lens mold member and weighed to provide a pre-extracted polymeric oxime hydrogel contact lens product. Dry weight. The pre-extracted lens product is then contacted with the alcohol for about 6 hours and then hydrated with water. The hydrated spectacles were then dried at about 80 ° C for about 1 hour and then dried under vacuum at about 80 C for about 2 hours. The dried glasses were weighed to determine the dry weight of the lens body of the hydrogel contact lens. The dry weights are then compared to determine the amount of extractable material present in the pre-extracted polymeric rock hydrogel contact lens product. The pre-extracted polymeric lens product having a level of extractable component of about 40% produces a lens body having a dry weight of about 60% of the oxygenated hydrogel invisible eyeglasses of the pre-extracted lens product. The pre-extracted polymeric lens product having an extractable component content of about 70% produces a lens body having a dry weight of about 30% of the oxygenated hydrogel contact lens of the pre-extracted lens product, and the like. The amount of extractable material or extractable component present in the pre-extracted polymeric hydrogel contact lens product can be determined using the following equation: E = ((dry weight of pre-extracted lens product - extracted and Hydrating contact lenses 121842.doc -40 - 200817471 dry weight) / pre-extracted lens product dry weight) χΐ〇〇. E is the percentage of extractables present in the pre-extracted lens product. For example, the pre-extracted polymeric oxygenated hydrogel contact lens product can have a dry weight of about 20 mg. If the oxygenated hydrogel contact lens obtained from the product has a dry weight of about 17 mg, the hydrogenated hydrogel contact lens comprises a lens body having a dry weight of 85% by dry weight of the pre-extracted lens product. It will be appreciated that the pre-extracted lens product has an extractable component content of about 15% by weight. As another example, the pre-extracted polymeric hydrogel contact lens product can have a dry weight of about 18 mg, and if the dehydrated hydrogel contact lens obtained from the lens product has about 13 mg On dry weight, the Asahi Hydrogel contact lens comprises a mirror body having a dry weight of about 72% of the pre-extracted lens product. The pre-extracted polymeric hydrogel contact lens product has an extractable component content of about 28% by weight. In certain embodiments, the mirror body of the helium-oxygen hydrogel contact lens (i.e., the oxygenated hydrogel contact lens that has been subjected to the extraction and hydration procedures) is substantially more than 70% of the dry weight of the lens prior to extraction. For example, the dry weight of the lens body after extraction can be from about 70% to about 90% of the dry weight of the pre-extracted lens body. Some embodiments of the spectacles of the present invention comprise a lens body having a dry weight of from about 7% to about 78 Å/〇 of the dry weight of the pre-extracted lens body. In at least one embodiment, the helium oxygen hydrogel contact lens has a dry weight of about 74% of the dry weight of the pre-extracted lens body. Although the pre-extracted polymeric hydrogel contact lens product of the present invention contains an extractable material, the extracted form of the oxygenated hydrogel contact lens of the present invention has a very small amount (if not significant amount) in the resulting lens body. Extract the substance. In certain embodiments, the amount of extractable material remaining in the extracted spectacles is from about 0.1% to about 4%, such as from about 〇4% to about 2% by weight, of the amount 121842.doc-41-200817471. Such additional extractables can be determined by contacting the extracted contact lens with an additional volume of a strong solvent such as chloroform. In addition, since the extractable component is present and distributed throughout the polymerizable silicone hydrogel lens precursor composition and the pre-extracted polymeric oxygenated hydrogel contact lens product, the lens product and contact lens of the present invention can be Different from surface treated helium hydrogel contact lenses. Since the extractable component can be extracted from the lens product and is substantially absent from the hydrated contact lens, the lens products and contact lenses of the present invention can be distinguished from the oxygenated hydrogel contact lens having the polymeric wetting agent IPN. The silicone hydrogel contact lenses of the present invention may comprise lens bodies obtained from non-polar resin contact lens molds having substantially the same surface morphology upon inspection in the hydrated and dehydrated state. In addition, the hydrated mirror bodies may have a surface coarseness slightly smaller than the surface roughness of the dehydrated mirror body. For example, the lens body of the glasses of the present invention may have a surface comprising a nanometer size peak, which is apparent when analyzing the root mean square (RMS) roughness data of the surface of the lens. The mirror body may comprise a region between the peaks of the differential ridges between the peaks to provide a reduced degree of sag and substantially similar surface morphology. For example, although the peak height can be reduced when the lens body is hydrated, the peak shape remains substantially the same. Alternatively or additionally, embodiments of the non-polar resin molded oxygenated hydrogel contact lenses of the present invention may comprise visually visible when viewed with an electron microscope such as a scanning electron microscope, a transmission electron microscope, or a scanning transmission electron microscope. Identify the mirrors of the rich and poor areas. Based on the chemical analysis of 121842.doc -42- 200817471, it can be seen that the barren area is a region that is substantially or completely flawless. The lean zone may be larger than the surface treated helium hydrogel contact lens or the oxygenated hydrogel contact lens comprising the polymeric wetting agent IPN. It is possible to use a disease-removing body and a device such as an image analysis system available from Bi〇qUant (Tennessee) to determine the size of the rich zone, the barren zone or both. The image analysis software system can be used to outline the boundary of the rich and barren areas and to determine the cross-sectional area, diameter, volume and the like of the areas. In certain embodiments, the barren zone has at least 50% 'at least 60%, at least 7%, at least 8%, or at least 90% of the cross-sectional area greater than the barren zone of the other hydrogel contact lenses. . The unsurfaced mirror body of the present invention generally provides acceptable surface wettability for ophthalmology. In other words, in one embodiment, the mirror body of the helium oxygen hydrogel contact lens of the present invention is a mirror body that has not been surface treated. In other words, the lens body is produced without surface treatment of the lens body to provide an ophthalmically acceptable surface wettability. For example, the illustrative scope does not include a plasma treatment or additional coating to make the surface of the mirror more acceptable to the eye. While the lenses of the present invention have an ophthalmically acceptable surface wettability, some embodiments may include surface treatment if desired. Certain embodiments of the lenses of the present invention comprise cast molded component mirrors obtained from non-polar resin contact lens molds. Polymerized Hydroxyl Hydrogel Contact Lens The product refers to a product that is polymerized or cured in a non-polar resin contact lens mold. Alternatively, in another manner, the polymeric hemihydrate hydrogel contact lens product is produced in a non-polar resin contact lens mold. As discussed herein, the contact lens molds are J, 0e^, a cookware using a non-polar or hydrophobic resin material or a non-polar or hydrophobic resin material based on 121842.doc-43-200817471. These materials typically have a relatively large contact angle on their lens forming surface. The spectacles of the present invention may comprise a stupid surface of the front table A or a contact angle of less than 9 Å on the rear surface. The hydrated mirror body. The mirror body typically has less than 75. The mirror surface advances the contact angle, for example, the mirror body has a mirror surface advancing contact angle (in terms of): 74, 73, 72, 71, 7〇, 69, 68, 67,

U 66, 65, 64, 63, 62, 61, 6〇, 59, 58 57, 56 55, 54 53 '52, 51 or 50. The mirror body can also have less than about 75. The mirror surface recedes the contact angle. For example, the mirror body may have a mirror surface receding contact angle (in degrees) of about one of: 74, 73, 72, 71, 7〇, 69, 68, 67, 66, 65, 64, 63, 62, 61 , 60, 59, 58, 57, 56, 55, 54, 53 52 51 , 50 , 49 , 48 , 47 , 46 , 45 , 44 , 43 , 42 , 41 or 40 . In one or more embodiments, the mirror body has about 4 inches. To about. Then retreat the contact angle. The hysteresis as the difference between the advancing contact angle and the receding contact angle is usually from about 5° to about 25. . However, in some embodiments, the hysteresis is about 5. To about 15. Within the range 'although in some cases, the spectacles may have greater than about 25. It lags, but is still clinically acceptable. The advancing contact angle can be determined using conventional methods known to those skilled in the art. For example, a conventional drop shape method such as a sessile drop method or a trap bubble method can be used to measure the contact angle and the receding contact angle of the contact lens. The contact angle of the infusion and back water of the hydrogenated hydrogel contact lens can be used.

Kruss DSA 100 appliance (Kruss GmbH, Hamburg) and as DA Brandreth: &quot;Dynamic contact angles and contact angle 121842.doc -44- 200817471 hysteresis'·, Journal of Colloid and Interface Science, Vol. 62, 1977, pp. 205- Pp. 212 and R. Knapikowski, Μ Kudra: Kontaktwinkelmessungen nach dem Wilhelmy-Prinzip-Ein statistischer Ansatz zur Fehierbeurteilung", Chem. Technik, Vol. 45, 1993, pp. 179-185 and U.S. Patent No. 6,436,481 For example, the advancing contact angle and the receding contact angle can be determined using a trapping bubble method using a saline buffered saline (PBS; pH = 7_2). The glasses are plated on the quartz surface and rehydrated with PBS prior to testing. 1 minute. Use the automatic injection system to place the bubbles on the surface of the glasses. Increase and decrease the bubble size to obtain the receding angle (the platform is obtained when the bubble size is increased) and the advancing angle (the platform is obtained when the bubble size is reduced) Alternatively or additionally, the spectacles of the present invention may comprise a mirror body that exhibits a water dispel time (BUT) of greater than 5 seconds. In general, embodiments of the spectacles of the present invention comprising a mirror body having a water BUT of at least 15 seconds (such as 20 seconds or more) may have an ophthalmically acceptable surface wettability. The spectacles of the present invention generally comprise a modulus A lens body smaller than 丨·6 Mpa. The glasses are generally characterized by a modulus of between about 〇5 and about 1.5 mPa, preferably between 、6 and about 22 mPa. In one or more embodiments, the spectacles have a modulus between about 0.8 and about 0.1 MPa. For example, the mirror body can have a spoon. 2 MPa, MPa, i 〇Μ ρ^, 〇9 MPa, 〇8 Mpa, about 〇 / M ^ a, about 〇 · 6 MPa or about M · 5 Mpa modulus. Select the mirror body modulus to H ', the field is placed on the eyes when comfortable glasses and make the glasses wearer Adapting to the operation of the lens. 121842.doc -45- 200817471 The modulus of the mirror body can be determined using conventional methods known to those skilled in the art. For example, a contact lens having a width of about 4 mm is cut from the center portion of the lens. And the tensile modulus (unit: MPa) can be obtained by using Instron 3342 (Instron Corporation) at 25 ° C in air at least 75% humidity The initial slope of the stress-strain curve obtained by the tensile test at a rate of 10 mm/min was measured. The ion current of the lens body of the glasses of the present invention is typically less than about 5 x 1 〇 -3 mm 2 /min. While some of the spectacle lenses of the present invention may have an ion current of up to about 7 χ ι -3 mm 2 /min, the ion current is less than about 5 x 1 〇 -3 mm 2 /min, and when the contact lens does not include MPC, Reduce corneal dehydration staining. In certain embodiments, the ion current of the mirror body ranges from about 2 x 1 〇 _3 mm 2 /min to about 5 x 1 〇 3 mm 2 / min. For example, the ion current can be about 2xl〇·3 mm2/min, 2.5χ1 (Γ3 mm2/min, 3.〇xl (T3 mm2/min, 3·5χ10·3 mm2/min, 4·〇χ1〇· 3 mm2/min, 4·5χ1〇.3 mm2/min or about 5xl〇-3mm2/min. However, as described herein, the ion current can be greater than 7χ1〇-3 mm2/min, but still does not cause corneal dehydration staining or Other Bed Problems The ion current of the spectacle lens of the present invention can be determined using conventional methods known to those skilled in the art. For example, contact lenses or mirrors can be used substantially similar to U.S. Patent No. 5,849,811. The technique of Ionoflux Technique is described in the number. For example, the frog mirror to be measured is placed between the convex and concave portions of the device for retaining the glasses. The convex and concave portions include a flexible sealing ring between the spectacles and each of the convex or concave portions. After positioning the spectacles in the device for retaining the spectacles, 121842.doc -46-200817471 placing the device for retaining the spectacles on the threaded cover The cover is screwed onto the glass tube to define the material substance chamber. The material substance chamber can be filled 16 ml 0.1 molar NaCl solution. The receiving chamber can be filled with 80 ml of deionized water. The conductor of the conductivity meter is immersed in the deionized water of the receiving chamber and the stir bar is added to the receiving chamber. The chamber is placed in the incubator and 'the temperature is maintained at approximately 35 ° C. Finally, the material chamber is immersed in the chamber/room. 10 minutes after immersing the material chamber into the receiving chamber, each Conductivity measurement is performed every two minutes for about 20 minutes. The relationship between conductivity and enthalpy time should be substantially linear. The lens of the glasses of the present invention generally has high oxygen permeability. For example, the lens body has Dk is not less than 60 barrer oxygen permeability. Embodiments of the glasses of the present invention comprise Dk of about 80 barrer, about 90 barrer, about 100 barrer, about 110 barrer, about 120 barrer, about 130 barrer, about 140 barrer or more. The mirror body preferably has a Dk of from about 70 to about 110 barrer and more preferably from about 80 to 100 barrer. The Dk of the lens of the present invention can be determined using conventional methods generally known to those skilled in the art. In terms of The Dk value can be determined using the Mocon method as described in U.S. Patent No. 5,817,924. The Dk value can be determined using a commercially available apparatus of the model name Mocon Ox-Tran System. The glasses of the present invention are also acceptable for ophthalmology. The mirror body of the water content. For example, embodiments of the glasses of the present invention comprise a lens body having an equilibrium water content of not less than about 30%. In certain embodiments, the mirror body has an equilibrium water content ranging from about 40% by weight to about 60% by weight. For example, the spectacles provided herein can have an equilibrium water content of about 35%, about 40%, about 45%, about 50%, about 121842.doc -47 - 200817471 55%, about 60%, or even about 65%. . In one or more embodiments, the lens body has an equilibrium water content of from about 42 weights ❶/❶ to about 50% by weight. The water content of the lenses of the present invention can be determined using conventional methods generally known to those skilled in the art. For example, a water-cut oxygen hydrogel contact lens can be removed from an aqueous liquid, wiped to remove excess surface water, and weighed. The weighed glasses can then be dried in an oven under vacuum at 8 ° C, and the dried glasses can be weighed. The weight difference was determined by subtracting the dry eyeglass weight from the weight of the hydrated eyeglasses. The water content (%) is (weight difference / hydration weight) χ 100. The spectacles of the present invention may have values in the range between any combination of the specific values determined above, in addition to the specific values identified above. For example, the contact lenses of the present invention can have a water content of from about 42% to about 50%, an ion current value of from about 3 to about 5 (xl - 3 mm2/min), of about 52. To about 62. Before entering the contact angle, about 4 inches. Up to about 6 baht. Then retreat the contact angle, about $. To a hysteresis of about 15, a Young's modulus (Y〇ung, s moduli) of about 0.6 MPa to about 1.2 MPa, an elongation of at least about ι〇〇%, and combinations thereof. In certain embodiments, the elongation is from about 100 angstroms per metre to about 300%. As discussed herein, the spectacles of the present invention have the desire and characteristics to allow for the wear of the spectacles. For example, the spectacles of the present invention can be worn as wearing glasses every day, wearing glasses every week, wearing bi-weekly glasses, or wearing glasses every month. The spectacles of the present invention comprise a hydrated mirror body having surface wettability, modulus, ion current, oxygen permeability and water content which contribute to the comfort and usability of the lens. 0 121842.doc -48- 200817471 The hydrogel invisible eyepiece is a contact lens that corrects vision and has strong vision. The glasses can be spherical or aspherical. The glasses can be single focus or multifocal glasses, including bifocals. In certain embodiments, the spectacles of the present invention are rotationally stable spectacles, such as rotationally stable toric contact lenses. The rotationally stable contact lens can be a contact lens comprising a lens body comprising a ballast. For example, the mirror body can have a ballast, a surrounding ballast, and/or one or more thinned upper and lower regions. The spectacles of the present invention also include a scope comprising a peripheral edge region. The outer peripheral edge region may include a circular portion. For example, the peripheral edge region can comprise a rounded trailing edge surface, a rounded leading edge surface, or a combination thereof. In some embodiments, the peripheral edge is completely rounded from the front surface to the back surface. Thus, it will be appreciated that the lens body of the eyeglasses of the present invention can comprise a rounded peripheral edge. The spectacles of the present invention may comprise a lens body whose thickness distribution solves the problems associated with prior oxyhydrogel contact lenses but is still comfortable for the wearer of the eyewear. The hardness of the mirror body can be controlled by changing the thickness of the mirror body and the modulus of the mirror body. For example, a, the hardness of one of the areas of the contact lens can be defined as the product of the Young's modulus of the lens and the square of the thickness of the specified area. Thus, certain embodiments of the spectacles of the present invention may comprise a mirror having a central hardness (e.g., the center of the eyeglass or the center of the viewing zone) of less than about 0.007 MPa-mm2, a lens joint hardness of less than about 〇〇3 MPa-mm, or a combination thereof. body. The eyeglass joint can be defined as the junction of the eyeglass area and the bevel or (for non-beveled glasses) a point of about 12 mm from the edge of the eyeglass (see U.S. Patent No. 6,849,671). In other embodiments, the spectacles of the present invention may comprise a lens body having a center hardness greater than 〇·0〇7 MPa_mm2, a lens joint hardness greater than about 〇·〇3 MPa-mm2, or a combination thereof. 121842.doc -49- 200817471 The Shixi oxygen hydrogel contact lens of the present invention can be provided in a sealed bag. For example, the Dimensional (4-) shaped eyeglasses of the present invention may be provided in an aqueous solution, such as a physiological saline solution, stored in a package in a 2 package or other similar container suitable for delivery to a lens wearer. Suitable/liquid mixture includes ^4 acid salt buffered physiological saline solution and acid salt buffer solution. If necessary, the solution may include a disinfectant or may be free of disinfectant or preservative: If necessary, the solution may also include a surfactant such as poloxamer and the like.眼镜 The glasses in the sealed package are preferably sterile. For example, the spectacles can be sterilized prior to sealing the package or can be sterilized in a sealed package. The sterilized spectacles can be glasses that are exposed to the bactericidal amount of radiation. For example, the glasses may be autoclaved glasses, gamma irradiated glasses, ultraviolet radiation exposed lenses, and the like. The present invention is not limited to the specific embodiments described below. The spears are not otherwise exemplified. Otherwise, the practice of the present invention will be fully described in the literature using techniques such as polymer synthesis, hydrogel formation, and the like in this technical skill. Reagents and materials are commercially available unless specifically stated to the contrary. Methods for preparing open spectacles (e.g., neohydrogenated hydrogel contact lenses) are further described in the following patents: U.S. Patent No. (2), State No., No. 4,495,313, No. 4,565,348, No. 4,640,489, No. 4,889,664, No. 985'186 5 Tiger, 帛5, 〇39,459, 帛5,080,839, 121842.doc •50-200817471 5,094,609, 5,260,000, 5,607,518, 5,760,100, 5,850,107, 5,935,492 No. 6,099,852, 6,367,929, 6,822,016, 6,867,245, 6,869,549, 6,939,487, and U.S. Patent Publication Nos. 20030125498, 20050154080, and '20050191335. • In the following examples, Efforts have been made to ensure accuracy with respect to the numbers used (eg, volume, temperature, etc.), but some experimental errors and partial () differences should still be resolved. Unless otherwise noted, the temperature is in C and the pressure is at sea level. Atmospheric pressure or near atmospheric pressure. The following well-known chemical substances are mentioned in the examples, and in some cases, the abbreviations are as follows References. Abbreviations for Substance and Method ΑΕ : Allyloxyethanol DI: Deionized Hydrazine: Ethyl Methacrylate M3U: M3-U; α-ω-Bis(Methethyloxy Ethyl Ethyl Carboxyl • ethoxypropyl)·poly(dimethyloxane)_poly(trifluoropropylindenyl oxane) _ poly(ω-methoxy-poly(ethylene glycol) propylmethyl矽 烷 ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; 8〇〇, aMw=i6 2〇〇(Asahikasei Aime Co., Ltd.? Japan) 〇121842.doc -51- 200817471 〒3H6(OC2H4)pOCH3 ch3 ch3 ch3 C2H4CF3 ch3 ch3 H2C=CCOOC2H4NHCOOC2H4OC3H6SiO—(Si0)n- ('0)m-(Si0)h-Si-C3H60C2H40C0NHC2H40C0C=CH2 III II ch3 ch3 ch3 ch3 ch3 M3U coloring: dispersion of β copper phthalocyanine in M3U (% by weight). Copper phthalocyanine available from BASF as Heliogen Blue Κ7090 obtained. N,N-DMF : DMF ; N,N-dimethylformamide NVP: 1-vinyl-2-pyrrolidone (fresh distillation under vacuum) PDMS : polydimethyl methoxy hydride PDMS-total - PEG: block copolymer of polydimethylsiloxane and PEG, which contains 75% PEG and MW 600 (DBE712 from Gelest) PEG: polyethylene glycol PP: propyl propylene EGDMA: dimercapto acrylate B Glycol TETEGDVE: Triethylene glycol divinyl ether TPTMA: Trimethylolpropane trimethacrylate UV416: 2-(4-Benzylmercapto-3-hydroxyphenoxy)ethyl acrylate

Vazo-64: azobisisobutyronitrile (V-64; thermal initiator) VMA: N·vinyl-N-mercaptoacetamide (fresh distillation under vacuum) VM: vinyl methacrylate characterization of lens products Method of Advancing Contact Angle/Retraction Contact Angle The advancing contact angle can be determined using conventional methods generally known to those skilled in the art. For example, a conventional droplet shape method such as a sessile drop method or a trapping bubble method can be used to measure the contact angle and the receding contact angle of the contact lens provided herein. Hydrogenated hydrogel hidden 121842.doc -52- 200817471 The front and back water contact angles of the glasses can be used with Knxss DSA 100 appliances (Kruss GmbH, Hamburg) and such as DA Brandreth: &quot;Dynamic contact angles and contact angle hysteresis'' , Journal of Colloid and Interface Science, Vol. 62, 1977, pp. 205-212 and R. Knapikowski, M. Kudra: Kontaktwinkelmessungen nach dem Wilhelmy-Prinzip-Ein statistischer Ansatz zur • Fehierbeurteilung'', Chem. Technik, 45th Measured as described in Vol., 1993, pp. 179-185 and U.S. Patent No. 6,436,481. 〇 For example, the advancing contact angle and the receding contact angle can be measured using a trapped bubble method using phosphate buffered saline (PBS; ρΗ = 7.2). The lenses were spread on a quartz surface and rehydrated with PBS for 1 minute before testing. The bubble is placed on the surface of the lens using an automatic injection system. The bubble size can be increased and decreased to obtain a receding angle (a platform is obtained when the bubble size is increased) and an advancing angle (a platform is obtained when the bubble size is reduced). The modulus can be determined using conventional methods known to those skilled in the art to determine the modulus of the lens. For example, a contact lens having a width of about 4 mm can be cut from the center portion of the eyeglass, and the tensile modulus (in MPa) can be at least 75% at 25 ° C by using Instron 3342 (Instron Corporation). Humidity. The initial slope of the stress-strain curve obtained by tensile testing at a rate of 1 〇 mm/min was measured. Ion Current The ion current of the lens body of the glasses of the present invention can be determined using conventional methods known to those skilled in the art. For example, the ion current of the contact lens or lens body can be measured using a technique substantially similar to the ''Ionoflux Technique' described in U.S. Patent No. 5,849,811. For example, 121842.doc -53-200817471 The spectacles can be placed between the convex and concave portions of the device that retains the spectacles. The male and female portions include a flexible sealing ring between the spectacles and each of the convex or concave portions. After positioning the glasses in the device for retaining the glasses, place the device that retains the glasses in the threaded cover. Screw the cover onto the glass tube to define the material chamber. The material chamber can be filled with 16 ml 0.1 Moer concentration of NaC solution. The receiving chamber can be filled with ribbed ml of deionized water. The wire of the conductivity meter is immersed in the deionized water of the receiving chamber, and the stir bar is added to the receiving chamber. Place in the incubator and maintain the temperature at about 35. Finally, the material chamber is immersed in the receiving chamber. It can be started every two minutes after immersing the material chamber in the receiving chamber for 1 minute. Carry out electricity The measurement of the rate takes about 2 minutes. The relationship between conductivity and time should be substantially linear. Oxygen permeability can be determined using conventional methods known to those skilled in the art to determine the Dk of the glasses of the present invention. The Dk value can be determined using the Mocon method as described in U.S. Patent No. 5,817,924. The Dk value can be determined using a commercially available instrument of the model name Mocon Ox-Tran System. The equilibrium water content can be used generally in the art. Conventional methods are known for determining the water content of the lenses of the present invention. For example, a hydrated oxalate hydrogel contact lens can be removed from an aqueous liquid, wiped to remove excess surface water, and weighed. The weighed glasses are dried in an oven at 8 Torr in vacuum and then the dried glasses can be weighed. The weight difference is determined by subtracting the weight of the dry spectacles from the weight of the hydrated spectacles. The water content (%) is ( Weight difference / hydration weight) χ 100. Example 1 121842.doc -54- 200817471 Preparation of polymerizable oxygenated hydrogel contact lens precursor composition Zhao using the reagents and relative amounts specified below ⑦ The polymerizable hydrogel contact lens precursor composition. This adjustment is referred to herein is the composition with the formulation ,, ,, ΗΜ.

Table 1

Total The components in Table 1 were weighed and mixed to form a mixture. The mixture was filtered into a vial via a 2.2_2 〇〇 microinjection filter and stored for up to about 2 weeks. Ο (This mixture is referred to herein as a polymerizable silicone hydrogel contact lens precursor composition). In Table 1, each unit amount of each compound is provided in addition to the respective weight percentages (expressed by weight/weight; weight ratio). Since the relative shares of the components total up to a total of nearly 100, in this case, the weight percentages of the components are substantially the same as the relative components. The ratio of hydrazine to VMA in the polymerizable composition is 〇·36:1. Example 2 Manufacture of a Hydroxyl Hydrogel Contact Lens A large number of precursor compositions from Example 1 were degassed using a repeated vacuum/nitrogen rinse procedure. The degassed precursor composition was then placed in a concave non-polar 121842.doc -55-200817471 resin mold member. The filled female mold member is then closed by contact with a non-polar resin male mold member under the pressure required to achieve a tight fit. The curing was then carried out in a nitrogen batch oven in the following cycle: 30 mm Ν2 purification at room temperature, 60 min at 65 °C and 30 min at 100 °C. The demolding is performed by tapping the concave mold member of the contact lens mold such that the convex cookware member is released therefrom, wherein the polymeric oxygenated hydrogel contact lens product adheres to the male mold member. The mirror is removed by floatation or using a mechanical lens removal device. The floatation method involves soaking a convex mold member containing dry glasses

Ο In a bucket of water. The glasses usually leave the mold within about 1 minute. The gas is interposed between the contact lens product and the rotating male mold member and the exposed surface of the contact lens product by compressing and rotating the conjugated talc hydrogel contact lens product to its convex mold member. A vacuum is applied to perform mechanical removal. The separated glasses are then loaded onto a plastic tray for extraction and hydration at room temperature, and the spectacle disk containing the polymerized hydrogel contact lens product is immersed in a solvent liquid (such as 95% ethanol and 5% methanol). Industrial methylated alcohol (IMS) lasted 45 minutes. Then line up the magic agent and replace it with fresh secret, and repeat the method with IMS (3 times), 1:1 alcohol/water (1#) ADI water (3 times). Store the hydrated glasses in a glass vial containing (4) water. Or in a foamed package or stored in phosphate buffered saline at pH 7.1-7.5. The sealed vessel autoclave was treated at 12 Torr for 3 Torr. After the autoclave treatment Μ h, the glasses were measured. The obtained water-cut oxygen hydrogel contact lenses were weighed, and then dehydrated in an oven towel, and the weight was again (4) Dehydrated oxygenated hydrogel 121842.doc • 56· 200817471 The dry weight of the contact lens. Spectacle characteristics such as contact angle (including dynamic contact angle and static contact angle), oxygen permeability, ion current, modulus, elongation, tensile strength, water content, and the like are measured as described herein. The wettability of the hydrated hydrogel hydrogel is also detected by measuring the water dispersing time of the glasses. Eye compatibility was further tested during the dispensing study, where the contact lenses were placed on the human eye for hours, 3 hours or 6 hours or longer, and then clinical evaluation was performed. The oxygenated hydrogel contact lenses produced by the formulations of the present invention have an ophthalmically acceptable surface wettability. The hydroxyl hydrogel contact lenses have an equilibrium water concentration (Ewc) of 44-47% and have been determined to have an extractables content of about 26% by weight. The resulting hydrated contact lens has the following characteristics: Table 2 Characteristics - 1 &quot;P t * πτ &quot;&quot; - "Value - 1 equilibrium water content (EWC) 45-47% ~ Oxygen (Dk) - 91 barrer Static contact angle (capture bubble wetting angle) 36-38° Dynamic contact angle (forward contact angle) 58° Dynamic contact angle (reverse contact angle) 50° Hysteresis (forward-reverse) 8° Refractive index 1.40 ¥Substream _ - - 3 -4 0.8-1 · 0 MPa Tensile Strength 1 - - - , 〇·6_0·7 MPa Those skilled in the art to which the present invention pertains will appreciate that various modifications and other embodiments of the present invention are presented in the foregoing description. The benefit of the teachings. Accordingly, it is to be understood that the invention is not limited to the specific embodiments disclosed herein, such as the teachings of FIG. The exemplified embodiments, the two alternatives and the equivalents, as defined by the other disclosures, may be within the meaning of: =. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not limiting. Has cited a large number of public shackles The publications and patents cited are hereby incorporated by reference in their entirety in their entirety in their entirety in the entirety the the the the the the the the the the the the the the the the The block diagram of the composition, the lens product and the contact lens of the present invention. [Main component symbol description] 102 Placement 104 Closure 106 Curing 108 Stripping 110 Mirror 112 Extraction 114 Hydration 116 Package 118 Sealing and Sterilization 202 Polymerizable 矽Oxygen hydrogel glasses precursor composition Ο 121842.doc -58- 200817471 204 Pre-extracted polymeric oxime hydrogel contact lens product 206 Extracted oxime hydrogel contact lens product 208 Hydrated oxime hydrogel invisible glasses

U 121842.doc -59-

Claims (1)

200817471 X. Patent application scope: ~&quot;Poly-sigma composition, which contains α-ω-bis(methacryloxyethylethylenimine-based ethoxypropyl)-poly(dimethyl oxime Oxygen polycondensation (trimethyl propyl oxane) _ poly (ω_methoxy-poly (ethylene glycol) propyl methyl oxirane) Ν vinyl * methyl acetamide, methacrylic acid The ester, the ethylene glycol dimethacrylate, the allyloxy alcohol, and the radical initiator. The polymerizable composition of the above item 1, which further comprises a UV absorber, a colorant or a combination thereof. The polymerizable composition of claim 2, wherein the ultraviolet absorber is 2-hydroxy-4-propyl decyloxy ethoxybenzophenone. The polymerizable composition of claim 2, wherein the colorant The polymerizable composition of the invention, wherein the coloring agent is phthalocyanine blue. 6. The polymerizable composition according to claim 1, wherein the radical initiator is 2, 2 _ azobisisobutyronitrile. η 7. The polymerizable composition according to any one of claims 1 to 6, which comprises about 34% by weight of α_ω-bis(methacryl oxime) Ethylethylimidocarboxyethoxypropyl poly(dimethyloxane)-poly(trifluoropropylmethyloxirane poly(indenyl)-methoxy-poly(ethylene glycol) The polymerizable composition according to any one of claims 1 to 7, which comprises about 1% by weight of &gt; 1-vinyl-indole mercaptoacetamide. The polymerizable composition according to any one of claims 1 to 6, which comprises about 7% by weight of methyl methacrylate. The polymerizable composition according to any one of claims 1 to 6, which comprises约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约 约a polymerizable composition comprising: about 0.9% by weight of 2-perylene propylene oxyethoxy benzophenone. The polymerizable composition of item 5, which comprises about 0. 1% by weight of phthalocyanine blue. The polymerizable composition of claim 1, which comprises about 0.3% by weight of a free radical initiator. 15. The polymerizable composition of claim 1 comprising about 3 4% by weight 2α_ω_ bis (methane propylene oxyethyl imino yl ethoxy propyl) _ poly (xymethane) &gt; poly(difluoropropylmethyl decane) _ Poly(ω-methoxy-poly(ethanol) propylmethyl oxime), about 46% ❶/〇 Ν-vinylmethyl hydrazine fe about 17 weight 〇 / 〇 methyl methacrylate , about 5% by weight of ethylene glycol methacrylate, about 9% by weight of allyloxy alcohol, about 0.9% by weight of _4 propylene oxy oxy benzophenone 0.1% by weight of phthalocyanine blue and about 0.3% by weight of 2,2,-azobisisobutyronitrile. 16. The polymerizable composition of claim 1, wherein the polyoxohydrate oxygen extractable component is absent. 17. A hydroxyl hydrogel contact lens produced by the polymerizable composition of any one of 丨 to 16. 18. An oxygenated hydrogel contact lens formed by the composition of any one of the preceding claims, which is substantially free of extractable components. 19. A helium-oxygen hydrogel contact lens comprising the reaction product of the composition of any one of the items of 121842.doc 200817471, as claimed in claim 1. 20. A hydroxyl hydrogel contact lens by The following steps are: polymerizing the polymerizable composition of any one of claims 1 to 16 to form a pre-extracted polymeric hydrogel contact lens comprising an extractable component, extractable from the pre-extracted contact lens The components are extracted to form an extracted poly spectacles product, and the extracted polymeric spectacles product is hydrated to form a hydrazine oxy-hydrogel contact lens. 21. The oxygenated hydrogel contact lens of claim 20, Having an equilibrium water content in the range of from about 42% by weight to about 50% by weight and an oxygen permeability (Dj^xio·11) in the range of about 8 (Μιο barrer). 22, as claimed in claim 20 or 21. A hydroxyl hydrogel contact lens having a modulus of from about 66 to about 1.2 MPa. 23. The oxygenated hydrogel contact lens of claim 20, wherein the polymerizing comprises heating the polymerizable composition to greater than A temperature of about 5 5 . Spectacles having an equilibrium water content in the range of from about 42% by weight to about 5% by weight, an oxygen permeability (DkXlO·11) in the range of from about 80 to 100 barrei, and from about 6 to about 12 The modulus of Mpa, the ion current of about 2_5 (xl0·3 mm2/min), about π. to about 62. The previous contact angle, about 40 to 60. The back contact angle and about 5 to about 15. The oxime hydrogel contact lens of any one of claims 18 to 24, wherein the lens body comprises a circular peripheral edge. 26. The oxygen hydrogel of any one of claims 18 to 24 Contact lenses are selected from the group consisting of: (1) spherical glasses, (ii) aspherical glasses, (111) monofocal glasses, (iv) multifocal glasses, and (v) rotationally stable complex 121842.doc 200817471 curved surface The contact lens of any one of claims 18 to 26, which is in a sealed package. ^ 28·A type that has not been surface treated as in any of claims 18 to 27矽 矽 水 hydrogel contact lens. 29. A method of producing a polymerizable silicone hydrogel contact lens precursor composition, the method Including: a combination of α-ω-bis(methacryloxyethylethylenimino yloxypropyl)-poly(dimethyl oxime)-poly(trifluoropropylmethyloxime) Alkyl poly(ω-methoxy-poly(ethylene glycol) propylmethyl oxime... vinyl-fluorene-mercaptoacetamide, methyl methacrylate, ethylene glycol dimethacrylate An allyloxy alcohol and a free radical initiator are employed to thereby produce a polymerizable hydrogel hydrogel contact lens precursor composition. 30. The method of claim 29, further comprising an ultraviolet absorber in the combining step. 31. The method of claim 29 or 30, further comprising a coloring agent in the combining step. 32. The method of claim 30, wherein the ultraviolet absorber is 2-hydroxy-4-indolyloxyethoxybenzophenone. The method of claim 31, wherein the colorant is a phthalocyanine pigment. The method of claim 33, wherein the phthalocyanine pigment is phthalocyanine blue. The method of any one of claims 29 to 34, wherein the free radical initiator is 2,2'-azobisisobutyronitrile. 3. The method of claim 29, wherein the combining step comprises a combination: (1) about 30-40 weights • ... bis (methacryloxyethyl imine 121842.doc 200817471 carboxy ethoxy propyl propyl ())-poly(didecyloxane)-poly(trifluoropropylmethyloxirane)-poly(ω-decyloxy-poly(ethylene glycol)propylmethyloxane), ( Ii) about 40-50% by weight of cerium-vinyl-indole-methylacetamide, (iii) about 10-25% by weight of methyl methacrylate, and (iv) less than about 5 parts by weight. /◦Dimercapto ethylene glycol acrylate, allyloxy alcohol, 2-hydroxy-4-propenyloxy ethoxy dibenzophenone, phthalocyanine blue and 2,2f-azobisisobutyronitrile The combination. The method of claim 36, wherein the combining step comprises combining about 34% by weight of cardio-bis(methacryloxyethyliminocarboxycarbonylpropyl)-poly(dimethyl矽 矽 ) - - - - - 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍 仍N-methylacetamide, about 17% by weight of methyl methacrylate, about 0-5 wt% of ethylene glycol dimethacrylate, about i% by weight of allyloxy alcohol, about 〇.9 by weight 2% hydroxypropenyloxyethoxybenzophenone, about 1% by weight of phthalocyanine blue, and about 3% by weight of 2,2,-azobisisobutyronitrile. The method of any one of claims 29 to 37, further comprising polymerizing the polymerizable lens precursor composition to form a pre-extracted polymeric silicone hydrogel contact lens. 39. The method of claim 38, wherein the polymerizing step comprises heating the polymerizable lens precursor composition. 40. According to the method of claim 38, half of the pots - human 丄u, eight progresses are included in the polymerization prior to the polymerization of the polymerizable lens precursor composition + person, bottle, ugly substance placed in the non-polar resin invisible In the glasses mold. The method of claim 4, further comprising extracting the pre-extracted polymeric contact lens to form an extracted polymeric lens product substantially free of extractable components and hydrating the extracted The lens product is polymerized to form a helium oxygen hydrogel contact lens. 42. A lithothere hydrogel contact lens comprising the reaction product of the polymerizable composition of any one of claims 1 to 17, which is substantially free of extractable components 0 Ο 121842.doc